The Food and Drug Administration has drafted a current good manufacturing practices (CGMP) regulation for the production of pharmaceuticals used in PET imaging, the agency reported.
The regulation aims to establish minimum standards for the production and testing of PET drug products, taking into account some of the particular properties of these agents that are not adequately covered in existing CGMP regulations for other drugs, the agency said.
The FDA is publishing the proposed CGMP for a 90-day comment period, and will then prepare a final rule. Two years after the final rule takes effect, PET radiopharmaceutical producers will be required to submit new drug applications before marketing a PET drug, the FDA said.
More information is available on the FDA Web site.
By AuntMinnie.com staff writers
September 26, 2005
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